Use of a Share Decision Making Tool in the Care of Acute Cystitis Without Risk of Complication in Primary Care
- Conditions
- Cystitis
- Interventions
- Procedure: Standard medical careProcedure: medical shared decision
- Registration Number
- NCT04272281
- Lead Sponsor
- University Hospital, Bordeaux
- Brief Summary
the aim of this trial is to demonstrate that when caring women with symptoms of acute cystitis without any risk of complication, general practitioner may use share decision making tool to help patients better understand the stakes of taking antibiotics.
- Detailed Description
Each year, more than 2.000.000 patients visit their general practitioners for a acute cystitis. The scientific literature shows that acute cystitis without risk of complication cause complications, such as pyelonephritis, in a very rare cases. However, French guidelines systematically request an antibiotic therapy as soon as the diagnostic is confirmed with the only goal to lowering symptomatology.
Recent studies show that some informed women would like not to take antibiotics and pain-killers could be as effective as antibiotics. Canadian studies assessing share decision making tools in patients with acute respiratory infection have shown that matching antibiotic treatment with the patient values lower such prescription without any impact on clinical outcomes .
Investigators aim to assess a similar strategy in patients with acute cystitis. This study will compare a group following French guidelines versus one using a share decision making tool to determine if, after being informed of the benefice and risk of this treatment, patient still want an antibiotic. Targeting instead of systematic prescription will reduce antibiotic consumption.
After diagnostic of acute cystitis to a woman between 18 and 65 years, investigators check if they filing all study criteria and ask for authorization to add them to the study. Then they'll act following their group instruction, and get information (antibiotic prescription or not, score to the Activity Impairment Assessment (AIA) scale, Score to satisfaction scale). Then patients will be followed by phone contact on day 5, day 14 and day 90 after inclusion to get information on antibiotic use, AIA and satisfaction scores and clinical outcomes, such urinary infection. Data on antibiotics delivery by pharmacy will be obtained through National assurance database.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 169
- woman
- between 18 and 65 years
- symptom of acute cystitis without risk of complication
- affiliated to the French public welfare system
- with signed consent
- anomaly of the urinary canal
- pregnancy
- more than 3 cystitis during the last year
- cancer, immunosuppression
- hemopathy, fever
- back-pain
- severe renal failure
- refuse to give consent and previously participate to the study
- under guardianship
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard recommandation Standard medical care Patients recruited from general practitioner will receive the standard medical care Share making tool decision medical shared decision Patient recruited from general practitioner in this group will use a share making tool decision to adapt antibiotherapy
- Primary Outcome Measures
Name Time Method Use of antibiotic for acute cystitis without risk of complication Day 14 after inclusion (day 0)
- Secondary Outcome Measures
Name Time Method Recurrence of the infection Between Day 15 and Day 90 Infection reccurence will be assessed with the number of dispensation of antibiotics between day 15 and day 90.
Score at the "Activity Impairment Assessment" scale Day 0, Day 5 and Day14 Scale from 0 (never) to 4 (always) on several items about usuals activities limitations.
Score at the satisfaction scale Day 0, Day 5, Day14 and Day 90 Scale from 0 (not satisfied) to 10 (very satisfied) on satisfation about medical care.
Trial Locations
- Locations (1)
CHU de Bordeaux
🇫🇷Bordeaux, France